Silymarin (Milk Thistle) Does Not Affect Hepatitis C Virus Activity or ALT Levels in HCV Patients, but Users Report Fewer Symptoms and Better Quality of Life than Non Users

Many HCV patients use the herb silymarin (milk thistle), an alternative
therapy for HCV, in addition to or instead of standard treatment for chronic
hepatitis C virus infection. In a survey of patients with chronic hepatitis
C who participated in a National Institute of Diabetes and Digestive and
Kidney Diseases-sponsored long-term treatment trial for patients who had
failed to respond previously to antiviral therapy, approximately 40%
acknowledged to interviewers at the time of enrollment that they were
currently using or had in the recent past used herbal products for health
purposes.
This information was somewhat surprising because these were patients with
advanced liver disease who were clearly committed to conventional antiviral
treatment for chronic hepatitis C, having been so treated previously, some
on more than one occasion, but because they had failed to respond, were now
willing to accept treatment again with pegylated interferon for another 3
and a half years.

Among those who were or had used alternative therapies, silymarin was the
product of choice either on its own or together with other herbal products,
representing 72% of all the herbals taken.

These study results appear in the February 2008 issue of Hepatology,
published by Wiley & Sons on behalf of the American Association for the
Study of Liver Diseases (AASLD). The article was is also available online at
Wiley Interscience.

These results do not come from a rigorous scientific study because the
products used were self-administered by the patients who entered the trial
and no information was obtained on the duration or dose of the herbal taken.
Still, in comparing users with non-users, while no difference was found for
blood ALT or HCV levels between the two groups, the herbal users did report
somewhat fewer symptoms and a better quality of life.

The current recommended treatment for patients with HCV infection is
combination therapy with pegylated interferon and ribavirin. However, it
leads to a sustained virological response (SVR) in only a third to a half of
all patients with the predominant form of the infection in the U.S., namely
genotype 1, and it can cause unpleasant and sometimes serious side effects.

HALT-C Trial

The NIH study, referred to as the Hepatitis C Antiviral Long-Term Treatment
against Cirrhosis (HALT-C) Trial, was designed, therefore, to treat persons
with advanced chronic hepatitis C who had failed previous antiviral therapy
with the hope that the long-term treatment would reduce progression of the
chronic liver disease even if it did not affect the virus itself.

The reason for interviewing enrollees in the trial was to determine the
extent of use of alternative therapies in this committed group, since the
popularity of herbal products has increased in the U.S., many HCV patients
choosing to supplement, or even replace, the standard treatment with
herbals. Silymarin (milk thistle extract) has been the most popular option
for people with liver disease. Although it is the most frequent product
utilized, silymarin has not been rigorously studied using accepted
scientific approaches, and therefore such studies are clearly required and
warranted.

For the present survey, researchers interviewed all HALT-C participants on
past and current use of all prescription and non-prescription drugs,
including herbal medications, dietary supplements and other botanical
products. Of 1145 study participants, 56 percent said that they had never
used herbal products, while 23 percent were using them currently, some 60
different articles. Silymarin was by far the most common. Usage was higher
among men, among non-Hispanic whites, and among the more highly educated.
Interestingly, the researchers also found geographic disparities in
silymarin usage. It was most popular in Colorado, Michigan and Southern
California and least popular in Maryland and Massachusetts.

Conclusions

In comparing the clinical data of silymarin users and non-users, the
researchers found that "the levels of HCV RNA were not significantly
different between silymarin users and non-users," indicating no effect on
virus activity. Similarly, the product did not alter serum ALT levels,
indicating no effect on hepatic inflammation. However, after adjusting for
covariates, the data showed that silymarin users reported less fatigue,
nausea, liver pain, anorexia, muscle and joint pain and better general
health than non-users.

The better scores in a small number of symptoms among silymarin users
compared to non-users are insufficient to support the value of this
alternative therapy, the authors conclude. Compelling information can come
only if a scientifically valid study is performed. "Currently in progress,
therefore, is a properly designed prospective, randomized, controlled trial
in which a fully characterized, purified and standardized silymarin
formulation is being evaluated," they report.

This trial is supported by the National Center for Complementary and
Alternative Medicine (NCCAM) and by NIDDK, NIH.